FDA Adverse Event
Injury
Summary report: N
ACUTRAK CANNULATED DRILL
MDR report key: 384992
·
Received March 25, 2002
Report
- Report Number
- 3025141-2000-00002
- Event Type
- Injury
- Date Received
- March 25, 2002
- Date of Event
- December 14, 2000
- Report Date
- March 23, 2002
- Manufacturer
- ACUMED, INC.
- Product Code
- HTW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A SURGERY TO TREAT AN OLECRANON FRACTURE, THE END OF THE CANNULATED DRILL TIP SHEARED OFF DURING THE DRILLING OF A THIRD ACTRAK SCREW. THE DRILL TIP WAS LEFT IN THE PATIENT AND THE SURGEON INTENDS TO REMOVE IT WHEN HE REMOVES THE SCREWS AFTER THE UNION OF THE FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUTRAK CANNULATED DRILL | SURGICAL INSTRUMENT | HTW | ACUMED, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other |